Game over? That's a fatalistic view of a protocol
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Posted On: 06/11/2022 1:09:44 PM
Re: craigakess #124584
Game over? That's a fatalistic view of a protocol rejection. No, it wouldn't be "game over" if it's rejected and we don't have a partner. I'm not sure how you linked the two together because they're not related. Regardless, it simply means they make the required changes and resubmit the protocol. The FDA doesn't always agree with the first submittal as you may recall. Remember when we wanted four weekly injections for the covid trials but the FDA rejected it and made us go with two? It happens and it's not a death blow to the company.
Quote:
Here's my thought: If CYDY submits a P3 protocol and it gets rejected by the FDA and we still have no partner, it's "game over" so who cares anyway if they announce it.
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My comments are just my opinions and should NOT be taken as investment advice.
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